December

Board of Directors – 83rd meeting

Boardroom, Ville Saint-Laurent
Wednesday, December 2, 2009, at 12:30 p.m.

Present:
Mr. Jean-Pierre Allaire
Mr. René Carignan
Ms. Martine Carré
Dr. Martin Champagne
Ms. Hélène Darby
Ms. Carole Deschambault
Dr. Francine Décary
Dr. Marc Dionne
Mr. André Légaré
Dr. Serge Montplaisir
Dr. Patricia Pelletier

Absent:
Dr. Sylvain Bélisle
Mr. Wilson Sanon, observer from the Hemavigilance Committee

Guests:
Dr. Gilles Delage, Vice-President, Medical Affairs in Microbiology
Me Smaranda Ghibu, Vice-President, Legal Affairs
Mr. Guy Lafrenière, Vice-President, Administration and Finance
Mr. Gilbert Rodrigue, meeting delegate, Héma-Québec

1. Call to order
Jean-Pierre Allaire chaired the meeting. He welcomed the members and guests present.
Quorum was established, and the meeting was called to order at 12:30 p.m.

2. Adoption of the agenda
It was moved, duly seconded and unanimously resolved to adopt the agenda as submitted.
Item 8.5 "Recommendations by the SAC (November 9 and 10, 2009) and the RRAC (November 28, 2009)" will be discussed immediately after Item 5.4 "2008-2009 Demographic Report".

3. Adoption of the minutes of the 82nd meeting on October 22, 2009, including the closed-door discussion
It was moved, duly seconded and unanimously resolved to adopt the minutes of the 82nd meeting of the Board held on October 22, 2009, including the closed-door discussion, as submitted.

4. Business arising from the 82nd meeting on October 22, 2009
The document was reviewed.
Item 2 - Sickle-cell anemia: explore the possibilities of working with the public health authorities which are starting a screening campaign in the black community: this topic will be discussed at the next Board meeting.
The other items appear on the meeting agenda or will be discussed at subsequent meetings.

5. Safety of blood supply
5.1 Pathogens under surveillance
The Vice-President, Medical Affairs in Microbiology, presented the updated scorecard. The update generally concerned the number of cases.
There have been no developments concerning the new XMRV retro-virus (Xenotropic Murine Leukemia Virus-Related Virus) recently added to the scorecard. It is still being monitored by the management committee. Also, we are looking for partners to conduct a study of this virus and the possible implications for transfusion.

5.2 A(H1N1) flu
The contingency plan was deployed at the start of the second wave of the pandemic. The crisis cell has been meeting three times a week since. It is monitoring several indicators, in keeping with the plan.
No impact on the inventory has been reported. In fact, it is rather high as a result of the increased solicitation of donors at the start of the second wave, which was initiated according to the plan. Moreover, blood donation has not decreased, despite plan premises.
The employee absenteeism rate is not significantly higher than for the same period last year. Thus, no preventive measures to this effect contained in the plan have been applied.
This low rate can be explained by the fact that we estimate that two-thirds of the employees have been vaccinated.
Considering the situation, the steering committee is considering the possibility of ending the work of the crisis cell at its meeting of December 3.

5.3 Transfusion incidents and accidents in 2008
5.3.1 Post-transfusion reactions: IVIg
The discussion took place behind closed doors.
Dr. Martin Champagne joined the meeting.

5.4 2008-2009 demographic report
The Vice-President, Medical Affairs in Microbiology, presented the document briefly. The demographic report is a valuable tool used for making operating decisions.
In particular, the percentages of positive donations confirmed for HIV, VHC, VHB, HTLV and syphilis are stable or slightly down. The slight prevalence of these viruses is essentially the result of effective donor selection.
The Vice-President, Medical Affairs in Microbiology, left the meeting after the presentation of Item 8.5.1, which was discussed immediately after Item 5.4.

6. Financial Affairs
6.1 Operating statistics as at October 31, 2009
The Vice-President, Administration and Finance, joined the meeting.
He presented the document briefly. Notes explaining the revision of the objectives in terms of blood collections and losses of packed red blood cells during production. This modification became necessary after it was noted that some of the objections had been not been adequately evaluated. It was mentioned that this revision has no impact on the financial targets.
Finally, the statistics for November should reflect the inventory increase resulting from measures implemented for the A(H1N1) flu pandemic.
In this respect, the members asked if this inventory increase will result in an increase in loss of products due to their the expiry date.
The risk is minimal with an inventory of 11 to 12 days. However, measures will be taken to return it to normal
As for the losses that occur during production, they will be presented to the audit committee by labile product once per year.

6.2 2010-2011 budget, revised
The Vice-President, Administration and Finance, briefly presented the modifications to the budget approved by the Board on October 22.
Ninety percent of the needs for US currency for the next year were covered by purchases at a rate of $1.0671. The revised rate resulted in savings of $2.4M with respect to the budget presented last October, most of which affected stable products.
The budget and the quarterly forecasts were submitted to the Minister of Health and Social Services on December 1, 2009.
The audit committee was also informed about the revised budget during its meeting of December 2, 2009.
The Board members said they were satisfied.
Also, the letter from Approvisionnements Montréal approving the 2010-2011 rates was submitted.

6.3 Purchase of an automatic analyzer (capital investment worth more than $300,000)
The discussion took place behind closed doors.

7. Management report
7.1 Management statement
The discussion took place behind closed doors.

7.2 Strategic guidelines, 2009-2010
The document was reviewed briefly.
Several delays were reported concerning the initial deadlines, but no delays with the exception of certain R&D objectives. In the cellular engineering section, since the implementation of the CCSM required almost a full year, the end of the projects has been postponed to 2011.
This delay did not, however, have any impact on the fulfillment of the strategic objective to satisfy the requirements of the Board in matters of research and development.
During the review of the document, particular attention was paid to the projects and activities with deadlines that could surpass the end of this fiscal year.

7.3 Health Canada inspection reports
7.3.1 Montréal facility
The Health Canada report includes just a few level 3 ("other") observations representing a low risk.

7.3.2 Laval Globule centre
Health Canada submitted no observations. This result is remarkable since it is a new Globule centre.

7.4 AABB inspection
Héma-Québec received a perfect grade following the "surprise" visit by AABB representatives on November 10-11, 2009. They were particularly impressed by the rigorous organization of company practices and stressed the efficiency of the personnel during the audit.
It was moved, duly seconded and unanimously resolved to address a motion of congratulations to the employees and management of Héma-Québec for the results obtained during these inspections (Health Canada and AABB).

7.5 Senior management expense accounts
The discussion took place behind closed doors.
The Vice-President, Administration and Finance, left the meeting.

7.6 Formal notice: heart valves
The discussion took place behind closed doors.

7.7 Working Committee, Commission des droits de la personne et des droits de la jeunesse
The discussion took place behind closed doors.

7.8 Bill on no-fault compensation
The Vice-President, Legal Affairs, informed the members that the bill was adopted by the National Assembly on November 19, 2009. It is an omnibus bill that modifies various legislative provisions concerning health matters.
All products distributed by Héma-Québec will be covered, with the exception of products distributed outside Québec and those used for research projects. Also, the resulting compensation programme will be retroactive to Héma-Québec's first day of activity in 1998.
The regulations have been drafted but have not been enacted yet. Therefore, we must continue our efforts with the government to ensure that the regulations are adopted and that the plan goes into effect before our insurance is renewed on May 31, 2010.

7.9 Grands Prix québécois de la qualité
Héma-Québec received a major distinction as part of the 2009 Grands prix québécois de la qualité.
These awards are presented each year by the Premier of Québec to the most performing private companies and public organizations.
It is rare for a company to be recognized the first time it applies.
This recognition is all the more important since it acknowledges the excellence of all of Héma-Québec's activities.
It was moved, duly seconded and unanimously resolved to address a motion of congratulations to the employees and management of Héma-Québec for the distinction obtained as part of the Grands Prix québécois de la qualité.

8. Board business
8.1 Audit committee December 2, 2009

The committee chair informed the members that the audit plan for the fiscal year ending March 31, 2010 has been presented by the auditors.
There are no major changes with respect to the previous year, apart from the addition of a chapter on intangible assets, which includes software and patents.
However, Héma-Québec's classification with respect to accounting norms (application of IRFS or government standards) is still pending. It was pointed out that the act that created Héma-Québec imposed a certain distance from the government. Subjecting Héma-Québec to government standards could possibly reduce the appearance and reality of this distance.
In this respect, the Auditor General has been open to our representations and has invited us to present our position. The Vice-President, Administration and Finance, will draft a report on the situation and discuss the strategy to be adopted in this matter with the President. The President will evaluate the pertinence of holding a meeting of the executive committee to discuss the issue.

8.2 Human resources and remuneration committee
The discussion took place behind closed doors.

8.3 Safety advisory committee: November 9 and 10, 2010
8.3.1 Comments by the Board observer
The public health representative and Board observer for the SAC attended the first day of the meeting.
He made the following comments:
- The committee has been operating for 11 years. The members are very satisfied with the way it functions and the level of discussion.
- The committee supported the recommendation concerning variant Creutzfeldt-Jakob disease (plasma for frationation).
- Reduction of pathogens: studies on the quality of the products for which these techniques are used are starting to be published.
- Hemoglobin: practices vary widely throughout the world. The public health representative is of the opinion that we should eventually draft recommendations in this matter.
- The XMRV virus and the scientific interest it is generating were discussed. Q-fever was also discussed. It does not represent a major risk, but it would be interesting to document it more.
- West Nile virus: in the United States, the practices will be segmented by region in order to trigger individual tests. Héma-Québec has already implemented this way of doing things.

8.4 Recipient representatives advisory committee November 28, 2009
8.4.1 Comments by the Board observers
In addition to the topics discussed at the SAC, including the recommendation about plasma for fractionation, information points were presented, particularly transfusion incidents and accidents, the demographic report and an update on the A(H1N1) flu.

8.5 Recommendation of the SAC (November 9 and 10, 2009) and the RRAC (November 28, 2009)
8.5.1 Variant Creutzfeldt-Jakob: plasma for fractionation

The Vice-President, Medical Affairs in Microbiology, made a brief presentation following Item 5.4.
Since a clear downward trend has been noted with respect to vCJD for several years, the management committee adopted, on May 14, 2009, a proposal authorizing plasma from people who have spent less than one month in the United Kingdom to be sent for fractionation. This measure will replace the policy implemented in 1999 following the decision by the Board to the effect that if a donor had spent even a single day in the United Kingdom, his/her plasma could not be used for fractionation while it could be used for transfusion (if the donor had spent less than one month there). This policy results in an annual loss of 1,304 units of plasma as a result of simultaneous restrictions on the use of plasma associated with strategies to reduce the risk of TRALI and vCJD.
The members' questions were answered.
The Safety Advisory Committee and the Recipients' Representatives Advisory Committee approved the recommendation of the steering committee during their meetings of November 9-10, 2009 and November 28, 2009, respectively.
Considering the downward trend concerning variant Creutzfeldt-Jacob disease (vCJD) in the United Kingdom, the fact that vCJD is not transmitted by the stable products concerned, and the fact that the fractionation processes currently used result in a significant reduction in prion levels, it is proposed, duly seconded and unanimously resolved to approve sending plasma from donors who have spent less than one month in the United Kingdom for fractionation.

8.6 Scientific and medical advisory committee October 21, 2009
8.6.1 Comments by the Board observer

The academic representative and Board observer for the CCSM commented in particular on the renewed energy level of the R&D team. He is of the opinion that the Vice-President, Research and Development, has contributed to this significantly.
The research projects are diversified and complementary while respecting Héma-Québec's mission.
We also count on a growing number of students (post-doctoral, trainees, etc.) to ensure a quality succession.
Also, the teams focus more on innovation and are vigilant with respect to patentable inventions. Moreover, they are willing to take part in international outreach.
Finally, French is now the language used by the committee.

9. Documents submitted
The members reviewed the documents.

9.1 Minutes of previous meetings
9.1.1 Steering committee October 6, 2009
9.1.2 Audit committee October 20, 2009
9.1.3 Safety advisory committee: April 20-21, 2010
9.1.4 Research ethics committee November 13, 2009

The members would like to know more about the committee. To do this, they asked to have the President invited to the next Board meeting to discuss the mandate and the activities of the REC.

9.2 2008-2009 demographic report
9.3 Héma Express

  • One of our donors sets a Canadian record by making his 1000th donation (October 22, 2009)
  • A(H1N1) flu -– Various measures implemented for the pandemic period... (October 27, 2009)
  • A(H1N1) flu – a nurse at the end of the line... (November 6, 2009)
  • Multiple donations at Laurier Globule (November 11, 2009)
  • Grands Prix québécois de la qualité – Héma-Québec is a winner (November 13, 2009)
  • "Surprise" visit by the AABB: a perfect grade! (November 19, 2009)
  • A(H1N1) flu – Follow-up on certain measures (November 23, 2009)

9.4 Press releases

  • 1,000th blood donation sets a new Canadian record! Michel Thérien is honoured by Héma-Québec (October 26, 2009)
  • Blood donations and the A(H1N1) flu vaccine (October 27, 2009)
  • Grands Prix québécois de la qualité – Héma-Québec amongst the best-performing organizations in Québec (November 12, 2009)

10. Discussion with management absent
The President and CEO and the guests left the meeting.
Closed-door discussion.
The President and CEO and the guests returned to the meeting.

11. Miscellaneous business
There were no items under Miscellaneous business.

12. Next meeting: February 17, 2010, 12:30, Montreal
The next meeting will be held on Wednesday, February 17, 2010, in Montreal.

13. Adjournment
It was unanimously resolved to adjourn the meeting at 4:25 p.m.

________________________________________________________________
Mr. Jean-Pierre Allaire, FCA, President Dr. Francine Décary, Secretary